ISRCTN16017947已完成不适用
A phase III multicentre randomised clinical trial comparing rituximab with cyclophosphamide, doxorubicin, vincristine and prednisone given every 14 days and rituximab with cyclophosphamide, doxorubicin, vincristine and prednisone given every 21 days for the treatment of patients with newly diagnosed diffuse large B cell non-Hodgkin's lymphoma
niversity College London (UK)0 个研究点目标入组 1,080 人开始时间: 2006年10月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,080
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Aged over 18 years
- •2. Histologically proven Diffuse Large B Cell non-Hodgkin's Lymphoma (DLBCL) according to the current World Health Organisation (WHO) classification including all morphological variants. The B cell nature of the proliferation must be verified by the positivity with an anti-CD20 antibody. All histology will be reviewed by a central Lymphoma Trials Office pathology panel
- •3. No previous chemotherapy, radiotherapy or other investigational drug for this indication
- •4. Bulky stage IA (defined as lymph node or lymph node mass greater than 10 cm in diameter), stage II, stage III and IV
- •5. WHO performance status zero to two
- •6. Adequate bone marrow function with platelets more than 100 x 10^9/l, neutrophils more than 1.5 x 10^9/l at the time of study entry unless attributed to bone marrow infiltration by lymphoma
- •7. Serum creatinine less than 150mmol/l, serum bilirubin less than 35mmol/l and transaminases less than 2.5 upper limit of institutional normal range unless attributed to lymphoma
- •8. Normal MUltiple-Gated Acquisition (MUGA) scan or EchoCardioGram (ECG) without any areas of abnormal contractility. Patients must have an acceptable Left Ventricular Ejection Fraction (LVEF) = 50% (only applicable if aged over 70, known diabetic over 65, past history of cardiac disease or hypertension or abnormal resting ECG)
- •9. No concurrent uncontrolled medical condition
- •10. No active malignant disease other than basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix in the last ten years
- •11. Life expectancy more than three months
- •12. Adequate contraceptive precautions for all patients of childbearing potential
- •13. Written, informed consent
排除标准
- •1. T-cell lymphoma or transformed follicular lymphoma
- •2. Previous history of treated or non-treated indolent lymphoma. However, patients not previously diagnosed who have a diffuse large B-cell lymphoma with some small cell infiltration in bone marrow or lymph node may be included
- •3. Past history of heart failure or uncontrolled angina pectoris
- •4. Central nervous system, meningeal involvement or cord compression by the lymphoma
- •5. Cardiac contra-indication to doxorubicin (abnormal contractility on echocardiography or nuclear medicine examination [MUGA])
- •6. Neurological contra-indication to vincristine (e.g. pre-existing diabetic neuropathy)
- •7. Any other serious active disease
- •8. General status that does not allow the administration of eight courses of CHOP according to the investigator
- •9. Positive serology for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C
- •10. Medical or psychiatric conditions that compromise the patient?s ability to give informed consent
研究者
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